Suppliers / Shenzhen Hepalink Pharmaceutical Group
Shenzhen Hepalink Pharmaceutical Group
China Updated 9 July 2026
Shenzhen Hepalink Pharmaceutical Group is an API manufacturer based in China. It holds one active US drug master file. Its filings concentrate with MINSA (CR) and INVIMA (CO). Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 13 June 2025 as VAI.
2
registered plants
1 with an FDA FEI number
2
filings
across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.
Inspection history
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Shenzhen, China | Not on file |
| China, China | 3014772595 |
What they file, and where
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| MINSA (CR) | 1 | None |
| INVIMA (CO) | 1 | None |
| EMA | None | 5 |
| US FDA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 13 June 2025.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates